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May 21, 20231 min read

South Africa's SAPHRA: Updated Medicines Application Form Module 1.2.1

Recently (18 May 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated Application form template...

Mar 17, 20231 min read

Swissmedic: eCTD v4.0 Implementation Guide published

Earlier today (17 March 2023) Switzerland's SwissMedic released published the "Implementation Guide for eCTD v4.0" and the implementation...

Oct 13, 20221 min read

EMA Guidance: How to Fill the Application Form for Centralised Type IA and IB Variations

Recently EMA released an updated guidance document for the purpose of simplifying the completion of the application form process for...

Sep 17, 20221 min read

USFDA Guide: Updated eCTD 4.0 - TECHNICAL CONFORMANCE GUIDE,

Recently USFDA released an updated "Electronic Common Technical Document (eCTD) Technical Conformance Guide" that revised some sections...